search
Back to results

Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic exercises
Resistance exercises
Combined training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Aerobic Exercises, Resistance Training, Combined Training

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heart failure patients with ejection fraction greater than 35%

Exclusion Criteria:

  • Patients with unstable angina
  • Patients who had severe pain in the lower limbs
  • Patients with Blood pressure greater than 190/120mmHg were excluded
  • Patients who had positive contraindication for cardiac rehabilitation were not admitted in this study

Sites / Locations

  • Rawalpindi Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Aerobic exercises

Resistance exercises

Combined training

Arm Description

Treadmill and Cycle ergometer

unilateral leg press, Bilateral leg press, unilateral arm curls

Treadmill and Cycle ergometer along with resistive Training

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. Changes from the Baseline will be measured.
Minnesota living with heart failure questionnaire
Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered, 21-item disease-specific instrument for patients with heart failure. MLHFQ is an instrument which has been widely used to assess quality of life among heart failure patients. Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The MLHFQ has two domains; physical domain (eight items, score range from 0 to 40) and emotional domain (five items, score range from 0 to 25). Changes from the Baseline will be measured
6 Min walk test (Distance in meters)
Changes from the baseline, 6 Min Walk Distance (6 MWD) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Peak VO2 with formula
A generalized equation can be used to determined Peak rate of oxygen consumption (peak VO2). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is: Mean peak VO2(ml/kg/mins) = 4.948 + 0.023*Mean 6 MWD (meter) Changes From the Baseline will be measured.
Heart Rate/Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter. Crossly it was measure by Chest belt (Polar Heart Rate monitors). Changes from the Baseline will be measure.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2021
Last Updated
October 19, 2021
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT04937231
Brief Title
Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
Official Title
Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Aerobic Exercises, Resistance Training, Combined Training

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercises
Arm Type
Experimental
Arm Description
Treadmill and Cycle ergometer
Arm Title
Resistance exercises
Arm Type
Experimental
Arm Description
unilateral leg press, Bilateral leg press, unilateral arm curls
Arm Title
Combined training
Arm Type
Experimental
Arm Description
Treadmill and Cycle ergometer along with resistive Training
Intervention Type
Other
Intervention Name(s)
Aerobic exercises
Intervention Description
For Week 1 and 2 : Treadmill 3-5days/weeks Intensity: 50-70 vo2 peak Or HRR 60-80% Duration of 10-20 minutes For Week 3 and 4; Cycle ergometer 3-5days/weeks Intensity: 50-70 vo2 peak Or HRR 60-80% Duration of 30-40 minutes
Intervention Type
Other
Intervention Name(s)
Resistance exercises
Intervention Description
For Week 1 and 2; 2 x 10 rep (unilateral leg press) 4x 12 reps (Bilateral leg press 1 x 8 rep ( unilateral arm curls For Week 3 and 4; 1 x 10 reps Shoulder press 1 x15 rep Bilateral knee extension 1 x 10 reps Bilateral arm curls
Intervention Type
Other
Intervention Name(s)
Combined training
Intervention Description
For Week 1 and 2; Aerobic exercise on Treadmill along with dumbbell to perform upper limb exercises (biceps curls, side curls extensions, upright row, back fly) and used Thera band to perform lower limb exercises for 10-20 minutes For Week 3 and 4; Aerobic exercise on Treadmill along with dumbbell and Thera band to perform upper limb and lower limb exercises for 30-40 minutes
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. Changes from the Baseline will be measured.
Time Frame
4th week
Title
Minnesota living with heart failure questionnaire
Description
Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered, 21-item disease-specific instrument for patients with heart failure. MLHFQ is an instrument which has been widely used to assess quality of life among heart failure patients. Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The MLHFQ has two domains; physical domain (eight items, score range from 0 to 40) and emotional domain (five items, score range from 0 to 25). Changes from the Baseline will be measured
Time Frame
4th week
Title
6 Min walk test (Distance in meters)
Description
Changes from the baseline, 6 Min Walk Distance (6 MWD) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Time Frame
4th Week
Title
Peak VO2 with formula
Description
A generalized equation can be used to determined Peak rate of oxygen consumption (peak VO2). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is: Mean peak VO2(ml/kg/mins) = 4.948 + 0.023*Mean 6 MWD (meter) Changes From the Baseline will be measured.
Time Frame
4th Week
Title
Heart Rate/Pulse Rate
Description
Changes from baseline, Pulse rate was measured per minute through pulse oximeter. Crossly it was measure by Chest belt (Polar Heart Rate monitors). Changes from the Baseline will be measure.
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart failure patients with ejection fraction greater than 35% Exclusion Criteria: Patients with unstable angina Patients who had severe pain in the lower limbs Patients with Blood pressure greater than 190/120mmHg were excluded Patients who had positive contraindication for cardiac rehabilitation were not admitted in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawalpindi Institute of Cardiology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients

We'll reach out to this number within 24 hrs